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Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.
60 women undergoing genetic amniocentesis will be enrolled at the Obstetric Unit, University of Ferrara. The selected patients will be randomly assigned to receive 300 mg of vaginal Lactoferrin to obtain 3 groups: A, 20 untreated patients; B and C (20 patients each one) respectively treated 4 and 12 h before amniocentesis. Cytokines, chemokines and growth factors concentrations will be quantified by a magnetic bead Luminex multiplex immunoassays panel technology.
Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - untreated | No Intervention | The patients will be not treated with vaginal lactoferrin | |
| B - 4 hrs treatment | Active Comparator | The patients will be administered with a single dose of 300 mg vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis. |
|
| C - 12 hrs treatment | Active Comparator | The patients will be administered with a single dose of 300 mg vaginal lactoferrin 12 hours prior to mid-trimester genetic amniocentesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amniotic fluid concentration of mediators involved in inflammation | The investigator will measure the amniotic fluid concentration of 47 mediators (cytokines, chemokines and growth factors) involved in the inflammatory process by Luminex multiplex immunoassays. Controls and Lactoferrin-treated patients will be compared by parametric or non-parametric statistical tests. | 1 month after the enrollment of patients will be concluded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetric Unit, University of Ferrara | Cona | Ferrara | 44124 | Italy |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |